Hospira Inc. LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01
Brand
Hospira Inc.
Lot Codes / Batch Numbers
List 12163-01, lot 39-126-5H
Products Sold
List 12163-01, lot 39-126-5H
Hospira Inc. is recalling LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prev due to The tubing can separate from the set at the filter inlet post.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tubing can separate from the set at the filter inlet post.
Recommended Action
Per FDA guidance
Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026